The present invention relates to connection with a closed container comprising a neck, the opening of which is plugged by a stopper made of a relatively soft material, for example made of elastomer, and provided with an external annular lip, the said rigid container being, for example, made of glass. As a non-exclusive preference, this connection is used to provide communication between, on the one hand, the aforementioned closed container and, on the other hand, another closed container comprising an end piece, the opening of which is also plugged by a stopper made of a relatively soft and elastic material. This definition applies to various applications among which is included therapy or the administration of a medicinal product, in which case the closed container contains, for example, an active ingredient in the form of a powder, and the other container consists of a flexible pouch containing a liquid medium which can dissolve the powder or active ingredient of the container or place it in suspension, this all being in order to obtain a medicinal preparation in liquid form ready to be administered to the patient.
A connection device, or connector, intended to be assembled in a leaktight manner, on the one hand, with a closed container as previously described, comprising tearable or puncturable tamperproofing means keeping the stopper sterile and, on the other hand, with another container as previously described, itself also comprising tearable or puncturable tamperproofing means keeping the stopper present in the opening of the end fitting sterile without having to remove the tamperproofing means of the two containers to be connected, is described and proposed in accordance with the document WO-9003536.
This connection device comprises:
a cap intended to fit coaxially over the neck of the container plugged with the stopper, and also covered around the annular lip by the tamperproofing means covering and sealing the whole of the external part of the stopper; this cap is also designed to be fitted over the neck 3 and for this purpose has radially outward elasticity so that it can snap-fasten, by means of an internal annular ridge, under the annular lip of the neck of the container; moreover, this cap comprises a coaxial collar lengthening it and forming an internal bore, which will be dealt with later, PA1 a transverse element made of a flexible and elastic elastomeric material, attached to and arranged inside the cap, including a transverse wall designed to come into contact with the external part of the stopper; this transverse element comprises an axial end piece or sleeve tube fitted in a leaktight manner over the perforating end of the needle which will be dealt with later, this sleeve tube being closed and perforable at its end sealing the needle, PA1 means for connecting with the inside of the container, through the stopper, comprising a piston mounted so that it can slide in the bore of the collar of the cap, and a central needle passing through the said piston and including the aforementioned perforating end, capped inside the sleeve tube or end piece of the transverse element made of elastomer. PA1 an axial and exterior sleeve tube which is of a single piece with the stopper made of elastomeric material, at its blind end forming a membrane which can be perforated by the central needle PA1 means for connection with the inside of the container, these consisting solely of a central or axial needle held in the aforementioned sleeve tube by its perforating end, PA1 a tubular cap sealed by a rim to the annular rim of the neck of the container, PA1 a protecting means or lid, lengthening the cap coaxially by use of a manual separation means, such as a circumferential line of weakness of the plastic, the lid and the cap together being arranged to cover the needle of the connection means, and especially its other perforating end, coaxially. PA1 first of all, the cap is designed to fit directly over the neck of the container, and come into contact with its wall, PA1 the transverse wall of the cap is made of a relatively hard material so that it comes directly to rest against the external part of the stopper, and it has a central opening for the passage of the needle from its disconnected position to its connected position, perforating the stopper, PA1 in addition, an external sleeve is provided which is designed to slide coaxially between and outside of the internal cap, having a circumferential continuous band, provided along one of its edges with an internal annular ridge for snap-fastening under the free rim of the internal cap; this band is sufficiently radially elastic to fit tightly against the internal cap and clamp the latter and snap-fasten by means of the annular ridge under the free edge of the internal cap, but strong enough to be indivisible, unless there is a desire to destroy it. PA1 a means for protecting the connection means from the outside is also provided, in leaktight contact with the collar of the cap. PA1 first of all, it makes it possible to make maximum use of the inherent viscoelastic properties of the stopper, in terms of sealing, both with respect to the outside and with respect to the inside of the container. PA1 the means of the invention also make it possible to get away with relatively high tolerances both on the stopper in terms of thickness and on the annular lip of the container, also in terms of thickness, which means that when the aforementioned tolerances are at a maximum, the inside of the connection device remains sealed to the outside. PA1 the connection device remains compatible with all standard containers as used particularly in pharmacy, and in accordance with the standards ISO4362-3 or ISO8362-1, PA1 the user has no visible or external means available which would allow him easily to force or to tamper with the connection device once the latter has been fitted permanently on the closed container. PA1 and this device can easily be fitted on the already-closed container without, in particular, modifying the lines or equipment used for packaging the product contained in the said container.
Such a device is not designed or suited to providing tamperproofing of the container with its stopper, because this tamperproofing is obtained by other means already present on the container. In particular, this device can be fitted and removed at will, relative to the plugged container.
Further, this device provides only temporary sealing, at the moment of connection, with each of the two containers in direct contact with their own sealing means.
A device for connection with a closed container, as previously defined, and completely closing this container, but without tamperproofing it in the sense that it is not put in place permanently on the container is described in accordance with the document U.S. Pat. No. C4624667.
This device interacts with a specific, non-standardized container which can be distinguished from the one described earlier by the presence of an annular rim running round the outside of the external annular lip and forming a housing for a flat, which is also annular, belonging to the stopper which in this case has a specific special shape.
The connection device proper comprises:
The cap previously described, of a single piece with the lid, does not fulfil a tamperproofing function in the sense that these elements may be detached from the annular lip of the container either deliberately or accidentally then put in place and bonded, for example, to this same lip, in which case the user has no visible indication or sign that the connection device has been tampered with, and particularly that the sterile conditions, in the case of the connection device being used in pharmacy or in therapy has been broken.